Kornimate/medical-research-clean huggingface dataset:
image guided radiotherapy (igrt) for prone partial breast irradiation

Conditions: Breast Cancer

Summary: partial breast irradiation (pbi) is becoming a new paradigm for breast cancer radiation.\[1\] no type i or ii evidence is currently available to demonstrate equivalence to standard whole breast radiotherapy, and a prospective randomized trial jointly sponsored by nsabp and rtog (nsabp b-39 and rtog 0413) is currently accruing patients, comparing whole breast radiotherapy to pbi, either by brachytherapy or external beam techniques (eb). until the results of this or similar trials are available, pbi remains a research domain, and it should be offered to patients only in the context of a clinical experimental protocol.

despite the fact that less extensive experience than that of brachytherapy is available, pbi delivery through an external-beam has many advantages. first of all, it is likely to be more acceptable to the patient since it is non-invasive and it does not require a surgical procedure or anesthesia. moreover, since it is delivered after surgery, the pathological analysis of the segmental mastectomy specimen is available to inform the selection of the best candidates. in addition, eb-pbi is likely to become more widely reproducible, since it does not rely on the experience and skills of the radiation oncologist performing the brachytherapy implant. besides, once the technique is established, it can be widely applied at any facility provided with a linear accelerator, without the risk presented by some brachytherapy approaches that can not be completed because of the unfavorable interplay of patient's anatomy with the technical limitations of the applicator. finally, in terms of health care economics, an external beam approach spares the costs of an extra surgical procedure and that of several days of hospitalization (in the case of ldr brachytherapy).

Eligibility criteria:
inclusion criteria: * post-menopausal women defined as either: 1. at least 2 years without menstrual period or 2. patients older than 50 with serological evidence of post-menopausal status or 3. hysterectomized patients of any age with fsh confirmation of post-menopausal status * pt1 breast cancer, excised with negative margins * pn0 or sentinel node negative or n0 clinically if the tumor is \< 1 cm in size exclusion criteria: * previous radiation therapy to the ipsilateral breast * presence of a proportion of dcis in the core biopsy specimen which is compatible with extensive intraductal component (eic)

Keywords: image guided radiation therapy partial breast irradiation breast cancer breast cancer breast preservation igrt pbi
study evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of sam-531 in healthy subjects

Conditions: Alzheimer Disease

Summary: to assess the safety and tolerability of ascending single oral doses of sam-531 in healthy subjects.to obtain preliminary pharmacokinetic (pk) and pharmacodynamic (pd) profiles of sam-531, an investigational drug, in healthy subjects and to evaluate the effect of a high-fat meal on the pk of sam-531 administered to healthy subjects.


Eligibility criteria:
inclusion criteria 1. men or women of nonchildbearing potential aged 18 to 45 years 2. elderly men or women aged 65 years and above as of study day 1. 3. body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg. body weight for elderly subjects must be ≥45 kg. exclusion criteria 1. any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease 2. any clinically important deviation from normal limits in physical examination, vital signs, digital 12-lead ecgs, or clinical laboratory test results. 3. tobacco use or the consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) or alcoholic beverages within 48 hours before study day 1, or grapefruit or grapefruit-containing products 72 hours before study day 1, and until the end of the inpatient confinement period.
effect of sleep on the recovery of patients admitted to the icu

Conditions: Critical Illness; Circadian Dysregulation; Delirium

Summary: the investigators plan to create several sleep/circadian rhythm friendly rooms within the medical intensive care unit to determine if decreasing sleep fragmentation effects recovery in patients hospitalized in the icu.

critically ill patients are known to suffer from severely fragmented sleep with a predominance of stage i sleep and a paucity of slow wave and rem sleep. the causes of this sleep disruption include the intensive care unit (icu) environment, medical illness, psychological stress, and many of the medications and other treatments used to help those who are critically ill. surveys have identified poor sleep as one of the most frequent complaints among patients who have survived a critical illness. patients in medical, cardiac, and surgical icus almost uniformly have fragmented sleep. although illness, pain, and medications contribute to sleep disruption in icu patients, the primary factor causing sleep disruption had been thought to be the icu environment. noise from various sources, including ventilators, alarms, television, phones, beepers, and conversation, have all been purported to disturb sleep in the icu. patients have reported that noise, specifically talking, is a frequent cause of sleep disruption in the icu. several studies have confirmed that peak noise levels in icus are far in excess of 45 db during the day and 35 db at night, which are the recommendations of the environmental protection agency for peak noise levels in the icu. the clinical importance of this type of sleep disruption in critically ill patients, however, is not known. the investigators hope to determine if placing patients in sleep/circadian rhythm friendly rooms will enable them to achieve better sleep, suffer from decreased delirium, and have improved recovery from their critical illness.

Eligibility criteria:
inclusion criteria: * any adult patient admitted to the micu with an expected length of stay of at least 3 days exclusion criteria: * frequent overnight neurological checks or frequent peripheral vascular checks
effect of medium chain triglyceride oil supplementation in mild cognitive impairment

Conditions: Mild Cognitive Impairment

Summary: the primary aim of this study is to assess whether daily dosing with medium chain triglycerides in subjects with mild cognitive impairment (mci) will improve cognitive performance.

twenty eligible subjects will be enrolled in the study that will consist of a baseline visit followed by six post-baseline visits. the control and placebo groups will each be comprised of ten subjects randomly assigned to the groups. the assessments at baseline will include concomitant medications, vital signs, height, and weight. in addition, subjects will complete a medical history questionnaire, and receive group instruction on incorporation of the study products into the diet from a registered dietitian. study products will be dispensed at each visit in excess of requirements, and re-issued at every visit after measurement of the remaining product that subjects will be instructed to bring to every visit. the post-baseline study visits will include body weight and vital sign measurements, concomitant medications, dispensation of study products, group instruction by a registered dietitian, and an assessment for adverse events. between study visits the subjects will receive a telephone call from the study coordinator to encourage compliance with the diet, and to ask about any adverse events. the study visits will conclude at week 24. the psychological tests conducted by clinicians at screening will be repeated during the cognitive testing visit.

Eligibility criteria:
inclusion criteria: 1. are male or female with a diagnosis of mild cognitive impairment 2. are 50 years of age or older exclusion criteria: 1. been on medication for mild cognitive impairment less than 90 days 2. major depression 3. uncontrolled hypothyroidism 4. known b12 deficiency 5. hepatic (liver) disease or insufficiency
study of gemini rechargeable spinal cord stimulation (scs) system

Conditions: Chronic Pain

Summary: the aim of this pre-market, prospective, single-arm, non-randomized, open-label, multi-center clinical study is to collect confirmatory data to show that the gemini scs neurostimulation system functions as intended in a clinical setting.


Eligibility criteria:
inclusion criteria: 1. subject is indicated for an scs system, or has an implanted scs system and is scheduled to receive an ipg replacement. 2. subject is scheduled to receive a new ipg permanent implant and has completed a successful scs trial in the last 6-months, or subject is scheduled to undergo an all-in-one procedure or has an implanted scs system for an approved chronic pain indication. 3. subject has a documented nrs pain score of ≥ 6 after at least 5 days without stimulation or has an implanted functioning scs system with nrs pain score of ≤ 4. 4. subject must provide written informed consent prior to any clinical investigation-related procedure. 5. subject is at least 18 years at the time of enrollment. 6. subject is capable and willing to recharge an implanted ipg. exclusion criteria: 1. subject's scs trial was unsuccessful. 2. subject is currently participating, or intends to participate, in another clinical investigation that may confound the results of this study, as determined by abbott. 3. subject has or will receive more than one ipg. 4. subject is pregnant or breastfeeding or plans to become pregnant during the clinical investigation follow-up period. 5. subject has other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's assessment, could limit the subject's ability to participate in the clinical investigation. 6. subject has or is scheduled to receive an intrathecal pump. 7. subject is part of a vulnerable population.

Keywords: gemini rechargeable scs system abt-cip-10407 ipg
mechanism and prevention of remote organ injury following ruptured aortic aneurysm

Conditions: Abdominal Aortic Aneurysm

Summary: it has been estimated that 80% of deaths from abdominal aortic aneurysms results from rupture. endovascular aneurysm repair (evar) has been applied to raaa (ruptured abdominal aortic aneurysm) patients with reports of improvements. despite the use of evar, patients have developed complications with lung and kidney function. this study will investigate certain biochemical processes that will potentially reduce these complications. knowledge gained from this study may also be used to further research in this field through larger studies.


Eligibility criteria:
inclusion criteria: * open/elective evar patients exclusion criteria: * patients who do not present with abdominal aortic aneurysms or ruptured abdominal aortic aneurysm

Keywords: open/elective evar patients
screening for frailty at home

Conditions: Healthy Volunteers

Summary: "many tools to evaluate frailty have been developed. however, at the time our study was designed, none of these instruments had been validated in terms of psychometric properties. the aim of this study was to validate the modified version of the short emergency geriatric assessment (segam) frailty instrument in elderly people living at home. it was an observational, longitudinal, prospective, multicentre study, set up in four departments (ardennes, marne, meurthe-et-moselle, meuse) in two french regions (champagne-ardenne and lorraine). subjects was aged 65 years or more, living at home, and was able to read and understand french, with a degree of autonomy corresponding to groups 5, or 6 in the aggir autonomy evaluation scale. assessment included demographic characteristics, comprehensive geriatric assessment, and the segam instrument. psychometric validation was used to study feasibility and acceptability, internal structure validity, reliability, and discriminant validity of the segam instrument. "

many tools to evaluate frailty have been developed. however, most are designed for use in the hospital setting, with the resultant drawback that they are not suitable for routine use in the community setting. a few tools have been developed for use in community-dwelling subjects, such as the cardiovascular health study (chs) developed by fried from a cohort of subjects aged 65 and older; the study of osteoporotic fractures (sof); or the share frailty instrument, developed in a cohort of the same name comprising subjects aged 50 years and older living at home. however, at the time our study was designed, none of these instruments had been validated in terms of psychometric properties. the aim of this study was to validate the modified version of the short emergency geriatric assessment (segam) frailty instrument in elderly people living at home. it was an observational, longitudinal, prospective, multicentre study, set up in four departments (ardennes, marne, meurthe-et-moselle, meuse) in two french regions (champagne-ardenne and lorraine). subjects was aged 65 years or more, living at home, and was able to read and understand french, with a degree of autonomy corresponding to groups 5, or 6 in the aggir autonomy evaluation scale. assessment included demographic characteristics, comprehensive geriatric assessment, and the segam instrument. psychometric validation was used to study feasibility and acceptability, internal structure validity, reliability, and discriminant validity of the segam instrument.

Eligibility criteria:
inclusion criteria: * age: 65 years or more * living at home * able to read and understand french * with a degree of autonomy corresponding to groups 5, or 6 in the aggir autonomy evaluation scale exclusion criteria: -
sacrocolpopexy versus vaginal mesh procedure for pelvic prolapse

Conditions: Vaginal Vault Prolapse; Enterocele; Uterine Prolapse; Cystocele; Rectocele

Summary: pelvic prolapse is one of the most frequent pathology in gynecology. recurrency of the prolapse after primary surgery is relatively high, 15-30%. sacrocolpopexy has showed to be effective but it requires a long learning curves and is more aggressive. new meshes techniques seem to be effective, as well, with less learning curve but they are expensive and there are no randomize studies published. the investigators aim is to compare both techniques in terms of: anatomical and functional efficacy, cost, operating time and complications.


Eligibility criteria:
inclusion criteria: * subject has been diagnosed with one or more clinically significant anterior, apical, or posterior genital prolapse disorder(s)(symptomatic pop-q stage ii or higher) requiring surgical repair. exclusion criteria: * investigator determines subject is not a candidate for surgical repair of her genital prolapse. * subject has had a prior prolapse procedure involving graft placement (synthetic or biologic) * subject has active or latent systemic infection or signs of tissue necrosis. * subject has restricted leg motion (inability to abduct or adduct leg positioning in the lithotomy position) with or without a hip replacement / prosthesis. * subject is currently pregnant or intends to become pregnant during the study period. * subject has had radiation therapy to the pelvic area. * subject has pelvic cancer, has had pelvic cancer within the past 12 months or has been on cytostatic medication within the past 12 months. * subject has uncontrolled diabetes. * subject is on any medication with could result in compromised immune response, such as immune modulators. * subject has undergone previous pelvic surgery \< 6 months prior to enrollment in this study. * subject is unwilling or unable to give valid informed consent. * subject is unwilling or unable to comply with the requirements of the protocol, complete all quality of life questionnaires and return for all follow-up visits. * subject with contraindications for laparoscopy

Keywords: sacrocolpopexy meshes sacrospinous ligament
special investigation for abrysvo in individuals aged 60 years or older

Conditions: Respiratory Syncytial Virus Infection

Summary: this post-marketing study is a multicenter cohort study in individuals aged 60 years or older vaccinated with abrysvo (rsv vaccine）designed to confirm the safety in individuals aged 60 years or older under actual clinical practice in japan.


Eligibility criteria:
inclusion criteria: 1. individuals aged 60 years or older who have been vaccinated with abrysvo for the first time after abrysvo is launched. those who have previously participated in the clinical trials of this product will be excluded. 2. vaccinated participants (or his/her legally acceptable representative) who understand the information on this study and have provided written consent regarding their participation in the study. exclusion criteria: -there are no exclusion criteria for this study.

Keywords: respiratory syncytial virus infection rsv vaccine individuals aged 60 years or older post marketing study
fmt treating constipation patients with depression and/or anxiety symptoms - clinical efficacy and potential mechanisms

Conditions: Constipation - Functional; Depressive Symptoms; Anxiety Symptoms; Gut-Brain Disorders

Summary: constipated patients often have mental problems such as depression and anxiety due to difficult defecation. our previous studies have proved the efficacy of fmt treating constipation. meanwhile it is believed that mental diseases are correlated to gut microbiota. this trial is based on the theory of the gut-brain-microbiota axis. patients with constipation, depression and/or anxiety are performed fmt, laboratory, imaging and microbiota examinations, and clinical follow-up, to observe the clinical efficiency of fmt and the potential role of gut microbiome in these gut-brain disorders.


Eligibility criteria:
inclusion criteria: * patients who were diagnosed as functional constipation (fc) according to rome ⅳ criteria were enrolled. * age ≥ 18 years * body mass index of 18-25 kg/m2. * hama ≥ 14 and/or hamd (17 items) ≥ 17 exclusion criteria: * history of sever mental disorders such as schizophrenia and bipolar disorder * history of organic intestinal disorders * history of gastrointestinal surgery * pregnant or breast-feeding women * infection with enteric pathogen * usage of probiotics, prebiotics, antibiotics within the last month * uncontrolled hepatic, renal, cardiovascular, and respiratory, or any diseases that in the opinion of the investigator, could affect intestinal transit and the intestinal microbiota. * patients who could not complete the follow-up

Keywords: fmt gut microbiota gut-brain disorder constipation depression anxiety
six months dhea treatment in female adrenal failure

Conditions: Adrenal Insufficiency

Summary: dhea is an adrenal deriven androgen precourser. the impact of dhea substitution therapy in adrenal failure is unknown as well as the physiologically effects of dhea is unknown. effects of physiologically dhea substitution is investigated in the model of female adrenal failure.


Eligibility criteria:
inclusion criteria: * female, * adrenal insuficiency, * stable and safe anticonception, * stable hydrocortison substituation treatment. exclusion criteria: * neoplastic and thromboembolic disease, * diabetes mellitus.
dexamethasone vs. dexmedetomidine for espb in pain management after knee arthroplasty

Conditions: Knee Osteoarthritis; Knee Arthritis; Knee Disease; Knee Pain Chronic

Summary: effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for knee arthroplasty

this study is proposed to explore the effect of perineurial dexamethasone and dexmedetomidine on erector spinal plane block duration for spine surgery. after spine surgery, patients need good analgesia. peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe. local anaesthesia's much lower toxicity threshold makes it essential for its safety. an effective adjuvant, such as dexamethasone or dexmedetomidine, could allow for a higher dilution of local anaesthetics while maintaining and enhancing their analgesic effect. there is considerable research comparing intravenous and perineural dexamethasone and dexmedetomidine use in orthopaedic surgeries. however, there is a massive lack of research regarding knee surgery and the erector spine plane block. in this study, investigators compare perineural dexamethasone and dexmedetomidine. the investigator aims to find a dexamethasone or dexmedetomidine that covers the need for good pain relief and fast recovery postoperatively.

Eligibility criteria:
inclusion criteria: * patients undergoing primary hip arthroplasty * aged \>18 years and \<100 years * asa physical status 1, 2 or 3. exclusion criteria: * if they refused to participate, * had a history of opioid abuse, * had an infection of the site of needle puncture, * were less than 18 years of age, * were postponed as having asa 4 or 5, * had an allergy to any of the drugs used in the study, * renal failure (estimated glomerular filtration rate \<15ml/min/1.73m2), * liver failure, * known or suspected coagulopathy, * pre-existing anatomical or neurological disorders in the lower extremities, * intellectual disability with problems in pain evaluation, * severe psychiatric illness.
exploring whether self-affirmation promotes reduced alcohol consumption in response to narrative health information

Conditions: Alcohol Drinking

Summary: this study tests the effects of a self-affirmation manipulation on (i) acceptance of a health message detailing the risks of alcohol consumption, (ii) engagement with the health message and (iii) alcohol consumption at 7-day follow-up. half of the participants complete a self-affirmation manipulation, where they reflect on their most important values, whereas the other half complete a control equivalent, where they reflect on their least important values. immediately post-intervention, all participants then receive information about the risks of alcohol consumption and complete measures of message acceptance and engagement with the materials. seven days after intervention, participants self-report their alcohol consumption in the previous 7 days.


Eligibility criteria:
inclusion criteria: * female * drinkers exclusion criteria: * male * non-drinkers